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Ventrax Delivery System
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Summary: The Ventrax Delivery System is a venous stent delivery device by Merit Medical Systems, cleared by the FDA via the 510(k) pathway. It is primarily used in venous stenting procedures, with evidence from 10 studies supporting its clinical application.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242873 ↗
Decision Date ?
January 15, 2025
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Ventrax Delivery System was cleared by the FDA on January 15, 2025, through the 510(k) pathway. It is manufactured by Merit Medical Systems and classified as a Class 2 device under product code DQY.
What It Is
The Ventrax Delivery System is designed for the delivery of venous stents. It facilitates the placement of stents within the venous system, aiding in the treatment of venous obstructions or insufficiencies.
FDA-Cleared Indications
- Delivery and deployment of a compatible venous stent within the venous vasculature.
- Use during percutaneous intravascular procedures requiring controlled placement of a venous stent.
Clinical Applications
- Percutaneous delivery of a venous stent to treat a narrowed or obstructed vein when stenting is indicated.
- Placement of a venous stent in the iliac or central venous system, when compatible with the device labeling and selected stent.
- Endovascular venous stenting performed under fluoroscopic or other appropriate imaging guidance.
Evidence Summary
The available literature includes 10 studies, with a mix of study types such as RCTs and case series, spanning from 2017 to 2023. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the Ventrax Delivery System is effective in delivering venous stents with high procedural success rates. The device has been associated with improved venous patency and reduced symptoms in patients with venous obstructions.
Safety Profile
Reported complications include minor procedural complications such as access site hematomas and transient pain. No major adverse events directly attributed to the device were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to evaluate the long-term safety and efficacy of the device in diverse patient populations.
Practical Considerations
- Use only with a compatible venous stent and guidewire or access system specified in the current manufacturer’s instructions for use.
- The appropriate device size depends on the target vessel, stent dimensions, access route and anatomy; operators should confirm compatibility before the procedure.
- The system is handled through percutaneous vascular access, commonly through a femoral or other suitable venous access site, with imaging guidance.
- MRI safety and conditional-use requirements should be confirmed in the current device labeling. The MRI status of the implanted venous stent is also relevant.
- Potential limitations include venous anatomy that cannot accommodate the delivery system, severe access-site disease, thrombosis or other contraindications to the planned stenting procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Ventrax Delivery System?
The Ventrax Delivery System is indicated for use in venous stenting procedures, particularly in cases of venous obstructions or insufficiencies.
What outcomes have been reported in clinical studies?
Clinical studies have reported high procedural success rates and improved venous patency with the use of the Ventrax Delivery System.
What complications have been reported?
Safety data from evidence indicate minor complications such as access site hematomas and transient pain, with no major adverse events directly linked to the device.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.